Professional Documents
Culture Documents
3 NICE guideline
4 Draft for consultation, January 2018
5
Who is it for?
Healthcare professionals
Commissioners and providers of services
People with rheumatoid arthritis, their families and carers.
This guideline will update and replace NICE guideline CG79 (published February
2009).
You are also invited to comment on recommendations that NICE proposes to delete
from the 2009 guideline.
Information about how the guideline was developed is on the guideline’s page on the
NICE website. This includes the evidence reviews, the scope, and details of the
committee and any declarations of interest.
Full details of the evidence and the committee’s discussion on the 2018
recommendations is in the evidence reviews. Evidence for the 2009
recommendations is in the full version of the 2009 guideline
2 Contents
3
4 Recommendations ..................................................................................................... 4
5 1.1 Referral, diagnosis and investigations........................................................... 4
6 1.2 Treat-to-target strategy ................................................................................. 5
7 1.3 Communication and education ...................................................................... 6
8 1.4 Initial pharmacological management ............................................................. 6
9 1.5 Further pharmacological management .......................................................... 7
10 1.6 Symptom control ........................................................................................... 8
11 1.7 The multidisciplinary team ............................................................................. 9
12 1.8 Non-pharmacological management .............................................................. 9
13 1.9 Monitoring ................................................................................................... 11
14 1.10 Timing and referral for surgery ................................................................. 12
15 Terms used in this guideline ................................................................................. 13
16 Recommendations for research ............................................................................... 14
17 Rationale and impact................................................................................................ 18
18 Investigations following diagnosis ......................................................................... 18
19 Investigations (ultrasound in diagnosis) ................................................................ 19
20 Treat-to-target strategy ......................................................................................... 20
21 DMARDs ............................................................................................................... 21
22 Short-term bridging treatment with glucocorticoids ............................................... 24
23 Symptom control ................................................................................................... 25
24 Monitoring ............................................................................................................. 26
25 Putting this guideline into practice ............................................................................ 27
26 Context ..................................................................................................................... 29
27 More information ................................................................................................... 30
28 Update information ................................................................................................... 31
29 Recommendations that have been deleted or changed........................................ 32
30
2 Recommendations
People have the right to be involved in discussions and make informed
decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show
the strength (or certainty) of our recommendations, and has information about
prescribing medicines (including off-label use), professional guidelines,
standards and laws (including on consent and mental capacity), and
safeguarding.
12 Investigations
13 These recommendations on investigations are for specialist care.
15 1.1.2 Offer to carry out a blood test for rheumatoid factor in adults with
16 suspected rheumatoid arthritis (RA) who are found to have synovitis on
17 clinical examination. [2009]
3 1.1.4 X-ray the hands and feet early in the course of the diseasein adults with
4 suspected RA and persistent synovitisin these joints. [2009, amended
5 2018]
1 1.2.2 Consider making the target remission rather than low disease activity for
2 people with an increased risk of radiological progression (presence of
3 anti-CCP antibodies or erosions on X-ray at baselines assessment).
4 [2018]
5 1.2.3 In adults with active RA, measure C-reactive protein (CRP) and disease
6 activity (using a composite score such as DAS28) monthly until the target
7 of remission or low disease activity is achieved. [2018]
To find out why the committee made the [2018] recommendations on treat-to-
target strategy and how they might affect practice, see rationale and impact.
16 1.3.3 Adults with RA who wish to know more about their disease and its
17 management should be offered the opportunity to take part in existing
18 educational activities, including self-management programmes. [2009]
20 Conventional DMARDs
21 1.4.1 For adults with newly diagnosed active RA:
To find out why the committee made the [2018] recommendation on short-term
bridging treatment with glucocorticoids and how they might affect practice, see
rationale and impact.
To find out why the committee made the [2018] recommendations on cDMARDs
and how they might affect practice, see rationale and impact.
12
17 The recommendations below are from NICE technology appraisal guidance 72. The
18 2009 guideline committee reviewed the evidence on anakinra and incorporated the
19 recommendations into the guideline. The technology appraisal was then withdrawn.
20 1.5.1 On the balance of its clinical benefits and cost effectiveness, anakinra is
21 not recommended for the treatment of RA, except in the context of a
22 controlled, long-term clinical study. [2009]
1 1.5.2 Patients currently receiving anakinra for RA may suffer loss of wellbeing if
2 their treatment were discontinued at a time they did not anticipate.
3 Therefore, patients should continue therapy with anakinra until they and
4 their consultant consider it is appropriate to stop. [2009]
5 1.5.3 Do not offer the combination of tumour necrosis factor-α (TNF-α) inhibitor
6 therapy and anakinra for RA. [2009]
7 Glucocorticoids
8 1.5.4 Offer short-term treatment with glucocorticoids for managing flares in
9 adults with recent-onset or established disease to rapidly decrease
10 inflammation. [2009]
11 1.5.5 In adults with established RA, only continue long-term treatment with
12 glucocorticoids when:
24 offer the lowest effective dose for the shortest possible time,
25 offer a proton pump inhibitor (PPI), and
26 review risk factors for adverse eventsregularly. [2018]
To find out why the committee made the [2018] recommendations on symptom
control and how they might affect practice, see rationale and impact.
15 Physiotherapy
16 1.8.1 Adults with RA should have access to specialist physiotherapy, with
17 periodic review (see 1.9.1, 1.9.2 and 1.9.3), to:
1 Occupational therapy
2 1.8.2 Adults with RA should have access to specialist occupational therapy,
3 with periodic review (see 1.9.1, 1.9.2 and 1.9.3), if they have:
13 1.8.4 The tailored hand exercise programme for adults with RA should be
14 delivered by a practitioner with training and skills in this area. [2015]
15 Podiatry
16 1.8.5 All adults with RA and foot problems should have access to a podiatrist for
17 assessment and periodic review of their foot health needs (see 1.9.1,
18 1.9.2 and 1.9.3). [2009]
19 1.8.6 Functional insoles and therapeutic footwear should be available for all
20 adults with RA if indicated. [2009]
21 Psychological interventions
22 1.8.7 Offer psychological interventions (for example, relaxation, stress
23 management and cognitive coping skills1) to help adults with RA adjust to
24 living with their condition. [2009]
25 NICE has a guideline on depression in adults with a chronic physical health problem.
7 1.8.9 Inform adults with RA who wish to try complementary therapies that
8 although some may provide short-term symptomatic benefit, there is little
9 or no evidence for their long-term efficacy. [2009]
14 1.9 Monitoring
15 1.9.1 Ensure that all adults with RA have:
22 1.9.3 Offer all adults with RA, including those who have achieved the treatment
23 target, an annual review to:
7 1.9.4 For adults who have maintained the treatment target (remission or low
8 disease activity) for at least 1 year without glucocorticoids, consider
9 cautiously reducing drug doses or stopping drugs in a step-down strategy.
10 Return promptly to the previous DMARD regimen if the treatment target is
11 no longer met. [2018]
12 1.9.5 Do not use ultrasound for routine monitoring of disease activity in adults
13 with RA. [2018]
To find out why the committee made the [2018] recommendations on monitoring
and how they might affect practice, see rationale and impact.
22 1.10.2 Offer to refer adults with any of the following complications for a specialist
23 surgical opinion before damage or deformity becomes irreversible:
1 1.10.3 When surgery is offered to adults with RA, explain that the main2
2 expected benefits are:
3 pain relief,
4 improvement, or prevention of further deterioration, of joint function,
5 and
6 prevention of deformity. [2009]
7 1.10.4 Offer urgent combined medical and surgical management to adults with
8 RA who have suspected or proven septic arthritis (especially in a
9 prosthetic joint). [2009]
10 1.10.5 If an adult with RA develops any symptoms or signs that suggest cervical
11 myelopathy3:
14 1.10.6 Do not let concerns about the long-term durability of prosthetic joints
15 influence decisions to offer joint replacements to younger adults with RA.
16 [2009]
18 Bridging treatment
19 Glucocorticoids used for a short period of time when a person is starting a new
20 DMARD, intended to improve symptoms while waiting for the new DMARD to take
21 effect (which can take 2 to 3 months).
1 Palindromic
2 Palindromic rheumatism is an inflammatory arthritis that causes attacks of joint pain
3 and swelling similar to RA. Between attacks the joints return to normal.
6 Step-up strategy
7 Additional DMARDs are added to DMARD monotherapy when disease is not
8 adequately controlled.
9 Step-down strategy
10 During treatment with 2 or more DMARDs, tapering and stopping at least 1 drug
11 once disease is adequately controlled.
12 Synovitis
13 Soft tissue joint swelling.
14 Treat-to-target
15 A treat-to-target strategy is a strategy that defines a treatment target (such as
16 remission or low disease activity) and applies tight control (for example, monthly
17 visits and respective treatment adjustment) to reach this target. The treatment
18 strategy often follows a protocol for treatment adaptations depending on the disease
19 activity level and degree of response to treatment.
23 1 Analgesics
24 What is the clinical and cost effectiveness of analgesic drugs other than non-
25 steroidal anti-inflammatory drugs (NSAIDs) in adults with rheumatoid arthritis (RA)
26 whose pain or stiffness control is not adequate?
24 The optimal dosing strategy and mode of administration for bridging glucocorticoids
25 also needs to be established. Although the anti-inflammatory response is dose
26 dependent, side effects of glucocorticoids vary according to both the dose and the
27 duration of treatment.
28 3 Ultrasound in monitoring
29 What is the clinical and cost effectiveness of using ultrasound to monitor disease in
30 adults with RA when clinical examination is inconclusive or inconsistent with other
31 signs of disease activity?
15 4 Ultrasound in diagnosis
16 What is the clinical and cost effectiveness of using ultrasound in addition to clinical
17 assessment when there is uncertainty about the diagnosis in adults with suspected
18 RA?
27 6 Subcutaneous methotrexate
28 What is the clinical and cost effectiveness of subcutaneous methotrexate compared
29 with oral methotrexate for adults with early onset RA starting a new DMARD?
24 Evidence suggests that all people with RA should be offered the same management
25 strategy; however, in the committee’s experience some people may respond less
26 well and have more progressive radiographic damage and impaired function.
27 Because the evidence was limited as to whether people with poor prognostic
28 markers should follow a different management strategy to improve radiographic and
29 functional (HAQ) outcomes, the committee agreed to make a research
30 recommendation.
8 Measuring functional ability at baseline will involve a change of practice for some
9 providers, but the cost is low and so it this is not expected to have a substantial
10 resource impact.
11 Full details of the evidence and the committee’s discussion are in evidence review B:
12 Risk factors.
24 Full details of the evidence and the committee’s discussion are in evidence review A:
25 Ultrasound for diagnosis.
1 Treat-to-target strategy
11 Monthly monitoring was recommended in the 2009 guideline, but the committee
12 acknowledged that many clinics do not monitor active disease this often. A regional
13 survey (Tugnet 2013) reported that about two-thirds of people with RA received
14 monthly CRP monitoring but only a quarter had monthly monitoring of disease
15 activity (with about 40% in dedicated early arthritis clinics) until disease control was
16 achieved. The committee were unsure whether these rates reflected practice across
17 England and noted that practice had improved since the survey was conducted in
18 2011. However, the committee agreed that monthly monitoring would likely involve a
19 change in practice in some clinics.
20 Full details of the evidence and the committee’s discussion are in evidence review C:
21 Treat-to target.
22 DMARDs
24 First-line treatment
25 Evidence showed that starting treatment with more than 1 conventional DMARD
26 (cDMARD) was no more effective than starting with a single cDMARD. The
27 committee agreed that cDMARD monotherapy might have fewer side effects and
28 recommended cDMARD monotherapy as first-line treatment. This differed from the
29 2009 guideline which recommended combination therapy. The difference is largely a
3 Many of the studies included in the 2009 guideline used cDMARDs that are no
4 longer commonly used in UK practice (for example, ciclosporin), and these studies
5 were excluded from the evidence for the 2018 update. In addition, the 2018 update
6 included new evidence published after the 2009 guideline. Further, a different
7 approach to analysing the evidence was taken, with the 2018 update aiming to
8 identify the most effective cDMARD strategy (monotherapy, sequential monotherapy,
9 step-up therapy, step-down therapy or parallel combination therapy) as well as which
10 cDMARD should be used. The 2009 guideline compared treatment strategies only,
11 regardless of the particular cDMARDs, and combined evidence according to
12 treatment strategy.
13 The evidence included in the 2018 update was therefore different to that included in
14 2009 and supported cDMARD monotherapy as first-line treatment.
15 Evidence from randomised controlled trials in people who had never had a DMARD
16 showed no consistent differences in the effectiveness of methotrexate, leflunomide
17 and sulfasalazine as monotherapies. The drugs also had similar costs. The
18 committee agreed that any of these drugs can be used as first-line treatment.
19 Hydroxychloroquine was less effective, but fewer people stopped treatment because
20 of side effects. The committee agreed that hydroxychloroquine could be considered
21 for people with mild or palindromic disease.
1 Further treatment
2 Evidence supported adding another cDMARD when needed (step-up strategy) rather
3 than replacing the cDMARD with another (sequential monotherapy). The committee
4 acknowledged that more side effects were possible with a step-up strategy, but in
5 their experience these could be managed by drug monitoring and were outweighed
6 by the clinical benefit of combination treatment when monotherapy was inadequate.
7 A published cost analysis supported a step-up approach rather than sequential
8 monotherapy.
9 Subcutaneous methotrexate
10 No evidence was found for subcutaneous methotrexate, but the committee agreed
11 that the effects may be superior and side effects fewer than with oral cDMARDs.
12 However, because subcutaneous methotrexate is significantly more expensive than
13 other cDMARD options, the committee was not able to recommend this without
14 evidence of clinical benefit and cost effectiveness relative to oral cDMARDs. The
15 committee decided to make a research recommendation to inform future guidance.
21 The 2009 recommendation to start with combination therapy was not widely adopted.
22 The 2016 National Clinical Audit for Rheumatoid Arthritis and Early Inflammatory
23 Arthritis reported that only 46% of people with RA received combination cDMARDs
24 at any time. Currently there is variation in practice regarding the choice of
25 cDMARD(s) and treatment strategy, with many healthcare professionals preferring to
26 start with monotherapy and only use combination therapy when response is
27 inadequate.
28 The 2018 recommendations to start with monotherapy and add drugs when the
29 response is inadequate are unlikely to have a substantial impact on practice or
30 resources, as they align with the current approach taken by many healthcare
31 professionals. However, the recommendations should result in a more consistent
1 treatment strategy and reduce the number of people prescribed combination therapy
2 on diagnosis.
3 The 2009 guideline recommended methotrexate as one of the first drugs used in
4 combination therapy. The 2018 recommendations do not specify which cDMARD
5 should be used at any stage of treatment. Again, this will be unlikely to have a
6 significant impact on practice, and methotrexate is likely to remain one of the most
7 commonly prescribed drugs.
13 Full details of the evidence and the committee’s discussion are in evidence review F:
14 DMARDs.
27 Because of the lack of good quality evidence, the committee decided to make a
28 research recommendation to determine the effectiveness of short-term
29 glucocorticoids for adults taking a new DMARD, including the most effective
30 regimen.
7 Full details of the evidence and the committee’s discussion are in evidence review H:
8 Glucocorticoids.
9 Symptom control
8 Full details of the evidence and the committee’s discussion are in evidence review G:
9 Analgesics.
10 Monitoring
11 Why the committee made recommendations 1.9.1, 1.9.2, 1.9.4 and 1.9.5
18 In people with established RA (RA for at least 2 years), the evidence suggested that
19 patient-initiated rapid access and scheduled medical review every 3 to 6 months
20 were similarly effective. The committee agreed that all adults with RA should have
21 rapid access to specialist care for worsening disease or disease flares, and ongoing
22 drug monitoring.
23 Ultrasound in monitoring
24 Randomised controlled evidence did not support using ultrasound for routine
25 monitoring of RA. However, in the committee’s experience ultrasound can be useful
26 for monitoring when clinical examination is inconclusive or is inconsistent with other
27 signs of disease activity (for example, pain or markers of inflammation). The
28 committee decided to make a research recommendation to inform future guidance
29 about using ultrasound in these situations.
6 Most people with RA currently have rapid access to specialist care when they have a
7 flare. The 2016 National Clinical Audit for Rheumatoid Arthritis and Early
8 Inflammatory Arthritis reported that 92% of people had access to urgent advice, with
9 97% of providers running a telephone advice line. Therefore the recommendation will
10 not affect current practice.
11 Use and availability of ultrasound varies widely across the country and even between
12 healthcare professionals in the same department. Some healthcare professionals
13 use it routinely whereas others use it on a case-by-case basis. The recommendation
14 should reduce the overall use of ultrasound while still allowing its use for selected
15 subgroups.
16 Full details of the evidence and the committee’s discussion are in evidence review E:
17 Frequency of monitoring.
20 NICE has produced tools and resources [link to tools and resources tab] to help you
21 put this guideline into practice.
22 [Optional paragraph if issues raised] Some issues were highlighted that might need
23 specific thought when implementing the recommendations. These were raised during
24 the development of this guideline. They are:
1 Putting recommendations into practice can take time. How long may vary from
2 guideline to guideline, and depends on how much change in practice or services is
3 needed. Implementing change is most effective when aligned with local priorities.
4 [Clinical topics only] Changes recommended for clinical practice that can be done
5 quickly – like changes in prescribing practice – should be shared quickly. This is
6 because healthcare professionals should use guidelines to guide their work – as is
7 required by professional regulating bodies such as the General Medical and Nursing
8 and Midwifery Councils.
15 Here are some pointers to help organisations put NICE guidelines into practice:
20 2. Identify a lead with an interest in the topic to champion the guideline and motivate
21 others to support its use and make service changes, and to find out any significant
22 issues locally.
25 4. Think about what data you need to measure improvement and plan how you
26 will collect it. You may want to work with other health and social care organisations
27 and specialist groups to compare current practice with the recommendations. This
28 may also help identify local issues that will slow or prevent implementation.
1 5. Develop an action plan, with the steps needed to put the guideline into practice,
2 and make sure it is ready as soon as possible. Big, complex changes may take
3 longer to implement, but some may be quick and easy to do. An action plan will help
4 in both cases.
5 6. For very big changes include milestones and a business case, which will set out
6 additional costs, savings and possible areas for disinvestment. A small project group
7 could develop the action plan. The group might include the guideline champion, a
8 senior organisational sponsor, staff involved in the associated services, finance and
9 information professionals.
10 7. Implement the action plan with oversight from the lead and the project group.
11 Big projects may also need project management support.
12 8. Review and monitor how well the guideline is being implemented through the
13 project group. Share progress with those involved in making improvements, as well
14 as relevant boards and local partners.
18 Also see Leng G, Moore V, Abraham S, editors (2014) Achieving high quality care –
19 practical experience from NICE. Chichester: Wiley.
20 Context
21 Rheumatoid arthritis (RA) is an inflammatory disease largely affecting synovial joints.
22 It typically affects the small joints of the hands and the feet, and usually both sides
23 equally and symmetrically, although any synovial joint can be affected. It is a
24 systemic disease and so can affect the whole body, including the heart, lungs and
25 eyes.
26 The incidence of the condition is low, with around 1.5 men and 3.6 women
27 developing RA per 10,000 people per year. The overall occurrence of RA is 2 to 4
28 times greater in women than men. The peak age of incidence in the UK for both
29 genders is the 70s, but people of all ages can develop the disease.
1 Drug management aims to relieve symptoms, as pain relief is the priority for people
2 with RA, and to modify the disease process. Disease modification slows or stops
3 radiological progression, which is closely correlated with progressive functional
4 impairment.
5 RA can result in a wide range of complications for people with the disease, their
6 carers, the NHS and society in general. The economic impact of this disease
7 includes:
11 the personal impact of RA and subsequent complications for people with RA and
12 their families.
13 Approximately one-third of people stop work because of the disease within 2 years of
14 onset, and this increases thereafter. Clearly this disease is costly to the UK economy
15 and to individuals.
16 More information
[The following sentence is for post-consultation versions only – editor to update
hyperlink with guideline number]You can also see this guideline in the NICE
pathway on [pathway title]. [Note: this should link to the specific topic pathway, not
to the overarching one.]
To find out what NICE has said on topics related to this guideline, see our web
page on [developer to add and link topic page title or titles; editors can advise if
needed].
For full details of the evidence and the committee’s discussions, see the evidence
reviews. [link to evidence tab]You can also find information about how the
guideline was developed, [link to documents tab] including details of the
committee.
2 Update information
3 This guideline is an update of NICE guideline 79 (published February 2009) and will
4 replace it.
10 NICE proposes to delete some recommendations from the 2009 guideline, because
11 either the evidence has been reviewed and the recommendations have been
12 updated, or NICE has updated other relevant guidance and has replaced the original
13 recommendations. Recommendations that have been deleted or changed sets out
14 these recommendations and includes details of replacement recommendations.
15 Where there is no replacement recommendation, an explanation for the proposed
16 deletion is given.
17 Where recommendations are shaded in grey and end [2009], the evidence has not
18 been reviewed since the original guideline.
19 Where recommendations are shaded in grey and end [2009, amended 2018], the
20 evidence has not been reviewed but changes have been made to the
21 recommendation. These may be:
1 These changes are marked with yellow shading, and explanations of the reasons for
2 the changes are given in ‘Recommendations that have been deleted or changed’ for
3 information.
6 Recommendations to be deleted
Recommendation in 2009 guideline Comment
In people with recent-onset active RA, Replaced by: Treat active RA in adults
measure CRP and key components of with the aim of achieving a target of
disease activity (using a composite score remission or low disease activity (1.2.1)
such as DAS28) monthly until
treatment has controlled the disease to a
level previously agreed with the
person with RA. [2009] (1.5.1.2)
Measure CRP and key components of Replaced by: In adults with active RA,
disease activity (using a composite score measure C-reactive protein (CRP) and
such as DAS28) regularly in people with disease activity (using a composite score
RA to inform decision-making about: such as DAS28) monthly until the target
- increasing treatment to control of remission or low disease activity is
disease achieved. (1.2.2)
- cautiously decreasing treatment
when disease is controlled. [2009]
(1.5.1.1)
2 ISBN: